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Post by boca1girl on May 6, 2022 4:57:42 GMT -5
Shelf life is not the issue with Afrezza. Share price on the other hand is... I was asking about the shelf life of T-DPI. My concern is if we have further delays for T-DPI, are finished goods at risk. Revenue will be recognized in 2Q with approval or quarter it is approved. You could limit your downside risk by selling covered calls if you fear another delay. I’m a long term investor, quarterly earnings are not as important as the long term trend. |
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Post by sayhey24 on May 6, 2022 5:50:57 GMT -5
Shelf life is not the issue with Afrezza. Share price on the other hand is... I was asking about the shelf life of T-DPI. My concern is if we have further delays for T-DPI, are finished goods at risk. Revenue will be recognized in 2Q with approval or quarter it is approved. You could limit your downside risk by selling covered calls if you fear another delay. I’m a long term investor, quarterly earnings are not as important as the long term trend. From a MNKD perspective shelf life doesn't really matter as the cost plus product has already been paid for. The revenue has just not been realized on the balance sheet which is an accounting thing. If the product were to expire UTHR would need to pay us to make more when the time comes. I think in a couple of weeks they will get the thumbs up from the FDA and they will be putting it in boxes. What will be interesting is if the label has any material changes. I would not be surprised if some warning words were added for technosphere but I don't expect it will be in a black box. |
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Post by Deleted on May 6, 2022 7:06:29 GMT -5
I was asking about the shelf life of T-DPI. My concern is if we have further delays for T-DPI, are finished goods at risk. Revenue will be recognized in 2Q with approval or quarter it is approved. You could limit your downside risk by selling covered calls if you fear another delay. I’m a long term investor, quarterly earnings are not as important as the long term trend. From a MNKD perspective shelf life doesn't really matter as the cost plus product has already been paid for. The revenue has just not been realized on the balance sheet which is an accounting thing. If the product were to expire UTHR would need to pay us to make more when the time comes. I think in a couple of weeks they will get the thumbs up from the FDA and they will be putting it in boxes. What will be interesting is if the label has any material changes. I would not be surprised if some warning words were added for technosphere but I don't expect it will be in a black box. If there is a change in the label that will delay the ROLLOUT and push Revenues into the 3rd Qtr. All of the packaging material will have to be edited. Now I'm hoping the FDA has already informed UTHR of any changes and it's already in process. We will not not until the approval. |
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Post by Clement on May 6, 2022 7:17:09 GMT -5
I think that they will not realize all the revenue at one time - it seems that it will be spread out over the contract period which goes for many years - thought I heard Binder say that. maybe months instead of years oops - sorry, it does look like years for recognition of deferred revenue. Binder said in the Q1 call: "Deferred revenue will be recognized over the manufacturing services agreement life, which currently runs to 2031. United Therapeutics is funding this cost as we've been invoicing and collecting from UT." (But we are receiving the cash now.) |
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Post by boca1girl on May 6, 2022 7:28:12 GMT -5
From a MNKD perspective shelf life doesn't really matter as the cost plus product has already been paid for. The revenue has just not been realized on the balance sheet which is an accounting thing. If the product were to expire UTHR would need to pay us to make more when the time comes. I think in a couple of weeks they will get the thumbs up from the FDA and they will be putting it in boxes. What will be interesting is if the label has any material changes. I would not be surprised if some warning words were added for technosphere but I don't expect it will be in a black box. If there is a change in the label that will delay the ROLLOUT and push Revenues into the 3rd Qtr. All of the packaging material will have to be edited. Now I'm hoping the FDA has already informed UTHR of any changes and it's already in process. We will not not until the approval. I started my career in the packing industry. If a label or product packaging is not finalized, you would have everything lined up at your printer to produce the label/packaging as soon as it was approved. You may also do a risk buy of multiple labels so you’re ready to to start packaging as soon as approval is granted. As you say, hopefully the FDA has already communicated the final label to UTHR but I doubt it because that would pre-announce their decision. I hope they have a good risk management plan and will be ready for whatever comes. |
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Post by sayhey24 on May 6, 2022 8:23:38 GMT -5
From a MNKD perspective shelf life doesn't really matter as the cost plus product has already been paid for. The revenue has just not been realized on the balance sheet which is an accounting thing. If the product were to expire UTHR would need to pay us to make more when the time comes. I think in a couple of weeks they will get the thumbs up from the FDA and they will be putting it in boxes. What will be interesting is if the label has any material changes. I would not be surprised if some warning words were added for technosphere but I don't expect it will be in a black box. If there is a change in the label that will delay the ROLLOUT and push Revenues into the 3rd Qtr. All of the packaging material will have to be edited. Now I'm hoping the FDA has already informed UTHR of any changes and it's already in process. We will not not until the approval. Why? How long does it take to go into Word and make a few updates and hit the print button? The warning would be on the paper insert in the box just like afrezza. |
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Post by sayhey24 on May 6, 2022 8:30:32 GMT -5
BTW - labels with the FDA are negotiated. Mike's reaction to the approval questions yesterday and him deferring to UTHR gave me the feeling there has been a bit of back and forth discussion. Aside from a feeling I have no data to base this on but I think UTHR, MNKD and the FDA want to get this done. A little give on the label could make the FDA CP lawyers happy. Of course a label without a black box is not going to make the diabetes cartel happy but too bad so sad.
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Post by brentie on May 6, 2022 11:55:10 GMT -5
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Post by Deleted on May 6, 2022 12:47:54 GMT -5
If there is a change in the label that will delay the ROLLOUT and push Revenues into the 3rd Qtr. All of the packaging material will have to be edited. Now I'm hoping the FDA has already informed UTHR of any changes and it's already in process. We will not not until the approval. Why? How long does it take to go into Word and make a few updates and hit the print button? The warning would be on the paper insert in the box just like afrezza. You think it's that easy? NOT |
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Post by Deleted on May 6, 2022 12:50:27 GMT -5
If there is a change in the label that will delay the ROLLOUT and push Revenues into the 3rd Qtr. All of the packaging material will have to be edited. Now I'm hoping the FDA has already informed UTHR of any changes and it's already in process. We will not not until the approval. I started my career in the packing industry. If a label or product packaging is not finalized, you would have everything lined up at your printer to produce the label/packaging as soon as it was approved. You may also do a risk buy of multiple labels so you’re ready to to start packaging as soon as approval is granted. As you say, hopefully the FDA has already communicated the final label to UTHR but I doubt it because that would pre-announce their decision. I hope they have a good risk management plan and will be ready for whatever comes. IMO the FDA Advisory Board is done with DPI. This is a LEGAL issue holding up the final approval. So I feel UTHR knows if there is a label change. We shall see. |
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Post by neil36 on May 6, 2022 13:16:45 GMT -5
I started my career in the packing industry. If a label or product packaging is not finalized, you would have everything lined up at your printer to produce the label/packaging as soon as it was approved. You may also do a risk buy of multiple labels so you’re ready to to start packaging as soon as approval is granted. As you say, hopefully the FDA has already communicated the final label to UTHR but I doubt it because that would pre-announce their decision. I hope they have a good risk management plan and will be ready for whatever comes. IMO the FDA Advisory Board is done with DPI. This is a LEGAL issue holding up the final approval. So I feel UTHR knows if there is a label change. We shall see. I agree Casper. I've sensed that the entire delay process is the FDA looking for (weak but plausible) excuses to play for time so the litigation can play out. Just my hunch. |
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Post by sayhey24 on May 6, 2022 13:31:15 GMT -5
Why? How long does it take to go into Word and make a few updates and hit the print button? The warning would be on the paper insert in the box just like afrezza. You think it's that easy? NOT Sure - once its negotiated. Look, lawyers have to bill so there is some degree of back and forth so they have hours to bill to but then you have the words and were they will appear on "the label". The words could be as simple as "Note - the inert carrier particle used to deliver Tyvaso to the deep lung - Technosphere had a concern raised during clinical trials when used as a carrier particle for insulin. During those trials with insulin several cases of acute bronchospasm were observed. During clinical use of Technosphere with insulin acute bronchospasm has not been observed. During Tyvaso trials no such occurrences of acute bronchospasm have been observed." Copy and paste that into the Word .doc and press the save button and then print. I guess some can always make things more difficult. Here is the current black box warning. I think my "Note" above would work for Tyvaso DPI. WARNING: RISK OF ACUTE BRONCHOSPASM IN PATIENTS WITH CHRONIC LUNG DISEASE See full prescribing information for complete boxed warning. • Acute bronchospasm has been observed in patients with asthma and COPD using AFREZZA. (5.1) • AFREZZA is contraindicated in patients with chronic lung disease such as asthma or COPD. (4) • Before initiating AFREZZA, perform a detailed medical history, physical examination, and spirometry (FEV1) to identify potential lung disease in all patients. (2.5), (5.1) |
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Post by sellhighdrinklow on May 6, 2022 14:13:38 GMT -5
IMO the FDA Advisory Board is done with DPI. This is a LEGAL issue holding up the final approval. So I feel UTHR knows if there is a label change. We shall see. I agree Casper. I've sensed that the entire delay process is the FDA looking for (weak but plausible) excuses to play for time so the litigation can play out. Just my hunch. Will someone please elaborate on the litigation theory and what exactly might be involved? I'm unclear. TYIA |
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Post by peppy on May 6, 2022 14:31:02 GMT -5
I think the typing of litigation is referring to LQDA/( UTHR.)
I could be wrong.
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Post by cretin11 on May 6, 2022 15:20:51 GMT -5
IMO the FDA Advisory Board is done with DPI. This is a LEGAL issue holding up the final approval. So I feel UTHR knows if there is a label change. We shall see. I agree Casper. I've sensed that the entire delay process is the FDA looking for (weak but plausible) excuses to play for time so the litigation can play out. Just my hunch. Is the litigation expected to play out fully in the next couple of weeks anyway? Not sure what the FDA would be accomplishing with such a delay. Or are you suggesting the FDA is trying to simply help LQDA by delaying the approval, but if so, why would the FDA favor little LQDA over larger UTHR. |
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